Pontiac native pushes for national right-to-try law

Friday

Sep 29, 2017 at 8:58 AM

Paul Westermeyer

The meaning of life is a subject that has dominated discourse throughout mankind’s existence, be we bound for an afterlife, borne back into an infinite cycle of reincarnation or whether our particles simply return to an inscrutable universe at our deaths. But for some people, particularly those who’ve had a clear expiration date stamped on their beings, life is its own justification, and should be fought for at any cost.

Mike DeBartoli, a Pontiac native now living in Sacramento, Calif., knows that he is dying. And he knows that nothing will stop him from dying. It’s an incredible burden he bears, yet he’s determined to make the time he has left perhaps the most useful that he’s lived.

DeBartoli, 55, was born in Pontiac. He grew into a 6-3 frame by the time he graduated from Pontiac Township High School in 1980. He pursued higher education at Southern Illinois University, where he played basketball. At the advice of a sibling, in 1985 the young man went west to California to pursue a firefighting career.

After a few years with the California Department of Forestry and Fire Protection, he eventually settled in Sacramento and joined the city’s fire department, where he worked for 28 years.

But nearly five years ago, a diagnosis of amyotrophic lateral sclerosis (more commonly called ALS and even more commonly known as Lou Gehrig’s Disease) cruelly dashed the plans, hopes and dreams he had had for himself.

The one-time brawny firefighter DeBartoli has since wasted away to half his weight, can no longer walk or use his hands and has significant trouble breathing, all progressively worsening symptoms of the exceptionally rare motor neuron disease.

“It’s kind of too late for me,” he said with a struggle. “I’m in hospice, and I’ve got less than six months. But I want to use this time I have to help others get a ‘right to try.’”

By “right to try,” DeBartoli is referencing the growing momentum of states’ enacting so-called right-to-try laws, which essentially enables unfortunate souls deemed to be terminally ill to fight for their lives with experimental drugs. This is done via circumvention of the Food and Drug Administration’s cautious process of trial-and-error, used to determine whether or not a new medicine is safe enough for public use.

Though some incarnation of right-to-try legislation has been enacted in 37 states, including Illinois and California in the respective years of 2015 and 2016, the laws are not without critics.

In a January 2015 article, the New England Journal of Medicine contended that “expanded-access programs can also raise concerns about equity,” noting that Medicare and many private insurers only cover treatments that are deemed “reasonable and necessary,” ultimately suggesting that “some observers have accordingly argued that expanded access generally favors the rich or well-connected over the poor.”

Further, in November of last year, the Harvard Health Policy Review denounced the laws as offering nothing that wasn’t already provided for by “compassionate use” requests, and accused the Goldwater Institute, the Libertarian think tank championing right-to-try laws, of using desperate people to undermine the FDA as necessary regulatory device.

Whatever the Goldwater Institute’s ultimate motivations, right-to-try laws do allow for limited access of medicines that have only passed the small-scale Phase 1 of clinical trials whereas “compassionate use” exemptions do not; medicine typically goes through four such phasal batteries of testing before it can be deemed safe.

“I’d rather be a guinea pig than not do anything at all,” DeBartoli said in response. “I get that there’s criticisms and concerns, I understand them, having to sign a waiver saying a doctor’s not liable if a medicine makes you sick or kills you, meaning our family can’t sue them. Which is fine, because we’re dying anyway.”

Calling the FDA “antiquated,” DeBartoli countered criticisms of right-to-try laws by saying that the chance, however remote, of a disease’s cure being discovered by those willing to take chances on radical treatments was, ultimately, not in the best interest of the pharmaceutical industry.

“The profit in a disease is not in curing the disease,” he stated. “It’s in treating it.”

What DeBartoli believes is lost in the debate over the ethics of right-to-try is the humanity and dignity of the dying themselves, and what time on this earth means to them.

“Some people said, ‘Oh, it’s false hope.’ But if you have a terminal disease, you have no hope,” he said. “Despite how rare this is, I lost a friend two years ago, Jim Broerman, who I went to high school with. I’ve testified in hearings of the California Senate for this right-to-try law, because I have hope that there will be a breakthrough, and that there would be accelerated approval.